systemic sclerosis
Conditions
Sponsors
Kyowa Kirin Co., Ltd.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Subject meets the diagnostic criteria defined in the Guidelines for Systemic Sclerosis (Japanese Dermatological Association 2016) at screening. - Onset of skin phenomenon within 60 months before enrollment - Moderate to severe systemic sclerosis with a modified Rodnan total skin thickness score (mRSS) of 10 to < 30 and progressive skin thickening at screening and at enrollment.
Exclusion criteria
Exclusion criteria: 1) Any of the following significant concomitant diseases: - Type 1 diabetes - Poorly controlled type 2 diabetes (HbA1c > 8.5%) - Congestive heart failure (Class II to IV of the New York Heart Association Functional Classification) - Myocartial infarction, unstable angina, or stroke occurring within 12 months before the first dose of investigational product - Poorly controlled hypertension (systolic pressure > 150 mm Hg or diastolic pressure > 90 mg Hg at screening) - Severe chronic lung disease (%FVC = 15 on the Patient Health Questionnaire-8 (PHQ-8) at enrollment (note: subjects with a total score of 10 to 14 on the PHQ-8 should be referred to a mental health care professional)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| pharmacokinetics serum KHK4827 concentration, Pharmacokinetic parameter from week 22 to week 24 safety Adverse events and side effects, anti-KHK4827 antibodies, C-SSRS, PHQ-8 | — |
Secondary
| Measure | Time frame |
|---|---|
| efficacy Change of mRSS from the baseline | — |
Countries
Japan
Outcome results
None listed